Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04653922
Status:
UNKNOWN
Last Update Posted:
2023-03-10
First Post:
2020-11-23
Brief Title:
Evaluation of Safety and Efficacy of a Bioengineered Corneal Implant for Treatment of Keratoconus
Sponsor:
LinkoCare Life Sciences AB
Organization:
LinkoCare Life Sciences AB
Study Overview
Official Title:
Evaluation of Safety and Efficacy of Intrastromal Implantation of LinkCor Bioengineered Corneal Implant for Management and Treatment of Keratoconus a Prospective Non-randomized Non-controlled Case Series
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LinkCor
Brief Summary:
This is a prospective Phase I open-label safety study to evaluate the safety feasibility and initial efficacy of a bioengineered corneal stromal substitute after implantation into the stroma of adults with advanced keratoconus The bioengineered substitute and implantation technique may provide a less invasive treatment option for advanced keratoconus than current surgical approaches that additionally does not rely on the limited availability of human donor corneal tissue
Detailed Description:
This is a Phase I open-label non-randomized non-controlled ongoing clinical case series in two participating centers in Indian and Iranian hospitals to evaluate the safety and feasibility of minimally-invasive surgery of advanced keratoconus using a bioengineered corneal stromal substitute on a compassionate basis to alleviate blindness and low vision due to the severely limited availability of human corneal donor tissue at these centers relative to the medical need Patients fulfilling inclusion criteria are recruited consecutively and implanted intra-stromally with the bioengineered substitute as a less invasive surgery than full-thickness or anterior lamellar corneal transplantation In the first phase of the study a total of 20 patients were recruited and safety and efficacy outcomes were evaluated in those having a minimum of 12 months of postoperative follow-up In the second phase of the study currently ongoing up to 40 patients are being recruited with one-year postoperative outcomes of all included patients to be evaluated as the final study endpoint Primary safety and efficacy outcomes will be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None